重组乙型肝炎疫苗(酵母)与乙型肝炎免疫球蛋白联合免疫阻断乙型肝炎病毒母婴传播的效果分析

Evaluation on Protective Efficacy of Recombinant Yeast Derived Hepatitis B Vaccines Combination With Hepatitis B Immune Globulin in Preventing Mother-to-infant Transmission of Hepatitis B Virus.

目的评价不同剂量(10μg×3和5μg×3)重组乙型肝炎(乙肝)疫苗(HepB)(酵母)与乙肝免疫球蛋白(HBIG)联合免疫阻断乙肝病毒(HBV)母婴传播的效果。方法在北京市、甘肃省和浙江省宁波市选择1997～2005年孕期或住院分娩时检测乙肝病毒表面抗原(HBsAg)阳性的母亲及其儿童,采用问卷调查和血清学检测(固相放射免疫)方法,比较不同剂量(10μg×3和5μg×3)重组HepB(酵母)与HBIG联合免疫阻断HBV母婴传播的效果。结果接种10μg×3重组HepB(酵母)无论是否与HBIG联合免疫,儿童HBsAg阳性率差异无显著的统计学意义(χ2=0.474,P>0.05),儿童HBsAg阳性率为2.15%,HBV母婴传播阻断率为97.47%。接种5μg×3重组HepB(酵母)与HBIG联合免疫的儿童HBsAg阳性率显著低于未联合免疫儿童(2χ=4.391,P<0.05),联合免疫儿童HBsAg阳性率为8.55%,HBV母婴传播阻断率为89.94%;未联合免疫儿童HBsAg阳性率为16.55%,HBV母婴传播阻断率为80.52%。其中母亲HBsAg和乙肝病毒e抗原(HBeAg)同时阳性(双阳性,下同)的联合免疫儿童,HBsAg阳性率为8.82%,非常明显的低于未联合免疫儿童(34.00%)(2χ=7.071,P<0.01);母亲HB-sAg阳性、HBeAg阴性的联合免疫儿童,HBsAg阳性率8.43%,未联合免疫儿童,HBsAg阳性率13.01%,差异无显著的统计学意义(χ2=1.243,P>0.05)。结论对母亲HBsAg阳性的儿童,重组HepB(酵母)与HBIG联合免疫阻断HBV母婴传播的效果,较未联合HBIG免疫者更佳,但接种10μg×3重组HepB(酵母)未联合HBIG免疫也能取得相同的保护效果,而接种5μg×3重组HepB(酵母)的儿童,尤其是母亲双阳性儿童,与HBIG联合免疫还是有必要的。

Objective To evaluate the protective efficacy in Preventing mother-to-infant transmission of Hepatitis B Virus （HBV）in two study designs with two doses of Recombinant Yeast derived Hepatitis B vaccines （HepB） （10 μg Vs5 μg）combination with Hepatitis B immune globulin （HBIG）. Methods In Beijing,Gansu Province, and Ningbo City,we selected mothers whose children were born between 1997 and 2005 and HBsAg positive when they were pregnant or childbearing,information about HBV infection of mothers and infants and HepB immunization of infants were compiled by questionnaires, blood serum was collected and HBV markers was tested by the solid-phase radio immunoassay （SPRIA）. The children were divided into 2 groups by ective efficacy and combination with HBIG were evaluated. Results In 10 μg group,the HBsAg posi tive rate was 2. 15% and the protective rate was 97.47%. There was no significant difference between the group combination with HBIG and with no HBIG （ χ^2 =0. 474,P〉0.05）. 5 μg group,the HBsAg positive rate for the children vaccinated with HBIG was higher than those vaccinated with no HBIG（χ^2 =4. 391 ,P〈0.05）. The HBsAg positive rate and the protective rate was 8. 55% and 89.94% for the children vaccinated with HBIG, and was 16.55% and 80.52% for the children vaccinated with no HBIG. For mothers both HBsAg and HBeAg positive,the HBsAg positive rate for the children vaccinated with HBIG was 8.82% and higher than with no HBIG（34.00%）（χ^2= 7. 071, P〈0. 01）. For mothers only the HBsAg positive,the HBsAg positive rate for the children vaccinated with HBIG was 8.43% and had no significant difference with no HBIG（13.0%）（χ^2 = 1. 243, P〉0. 05）. Conclusions The protective efficacy of HepB combination with HBIG excelled the group with no HBIG in the study,while the protective efficacy had no difference for the children vaccinated with 10 μg dose HepB whether combined with HBIG or not. For infants born to HBV carrier mothers immunization with 10 μg dose HepB it showed same protective efficacy. But for the infants vaccinated with 5 μg dose HepB,combination with HBIG would be better than with no HBIG especially for mothers both HBsAg and HBeAg positive.